MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN POLYSORB; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	GL-322
Medical Device Problem Code	Difficult To Position (1467)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/25/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during an open mastectomy procedure, surgeon was using a suture to secure allograph to patient and also to close tissue.The surgeon was using the suture in a tacking technique, using interrupted sutures.Was observed the surgeon using a 4 throw instrument tie technique, creating 2 square knots for each interrupted suture.After tacking 4 or 5 areas of the mesh, the surgeon observed that several of the knots had completely unraveled and were no longer securing the mesh.Another device was used to complete the case.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection and functional evaluation of the samples had acceptable results.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.If information is provided in the future, a supplemental report will be issued.

• Brand Name: POLYSORB
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mc dermott rd; north haven CT 06473
• MDR Report Key: 7038044
• Report Number: 1219930-2017-08836
• Device Sequence Number: 13730419
• Product Code: GAM
• UDI-Device Identifier: 20884521045245
• UDI-Public: 20884521045245
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K963253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: GL-322
• Device Catalogue Number: GL-322
• Device Lot Number: A7E0302X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2017
• Initial Date Received by Manufacturer: 10/25/2017
• Supplement Date Received by Manufacturer: 02/08/2018
• Initial Report FDA Received Date: 11/16/2017
• Supplement Report FDA Received Date: 02/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1